DADI Human Variations eAF User Acceptance Testing (UAT) – Call for Volunteers
In the context of the digitalisation of the Variations Application Form for Human Medicinal Products, the EMA is pleased to invite applicants to participate in the UAT of the Digital Application Dataset Integration (DADI) Network project.
UAT timeline and scope
The DADI UAT is planned to be conducted between 5th and 16th September 2022. During that period, the production-like version of the electronic Application Forms (eAF) Portal will be open for testing. As recently communicated, please note that the scope of this UAT is limited to Centrally Authorised Products (CAPs). The UAT participants are expected to perform testing activities by filling in electronic Application Forms as close as possible to real-life scenarios. Namely, this implies filling in an eAF for one or multiple CAPs, single scope or grouping of scopes from different variation procedure types (e.g., type IA or type IB), and exporting the PDF output to be included in a submission.
More information and how to register can be here.
DADI Human Variations eAF revised go-live scope
EMA will launch the eAF variations web form in October 2022. This is the first release of the web-based variation form for human medicinal products that will be improved and expanded in subsequent releases in 2023. This progressive release model follows the Agile development model of the Agency.
The scope of the October 2022 go-live will be limited to Centrally Authorised Products (CAPs). EMA made this decision due to the complexity of synchronising the data between xEVMPD and PMS.
A subsequent release of the form in March 2023 will support all types of EU variation procedures (CAPs and NAPs).
More information is available here.